A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

NCT02473731 | Completed Phase 1

• 1 other identifier: KTN3379-CL-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck cancer patients and to explore downstream molecular pathways to identify tumor response and resistance mechanisms by evaluating various biomarkers before and after treatment.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

CDX3379

Outcome Measures

Primary Outcomes (1)

• Change in pErbB3 levels in tumor tissue

  Reduction in pErbB3 levels

  4 weeks

Secondary Outcomes (5)

• Number of patients with adverse events as a measure of safety and tolerability

  6 weeks

• Ki67 proliferative index in tumor tissue

  4 weeks

• Changes in tumor measurements (RECIST 1.1 measurements)

  4 weeks

• Pharmacokinetics (Peak plasma concentrations of KTN3379 Trough plasma concentrations of KTN3379)

  4 weeks

• Anti drug antibodies

  6 weeks

Study Arms (2)

A

EXPERIMENTAL

Treatment with KTN3379 in HPV positive head and neck cancer patients

Biological: KTN3379

B

EXPERIMENTAL

Treatment with KTN3379 in HPV negative head and neck cancer patients

Biological: KTN3379

Interventions

KTN3379 BIOLOGICAL

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed primary, untreated SCCHN including variants. Patients must be candidates for surgical resection. Primary tumors of oral cavity, oropharynx, hypopharnyx or larynx are included.
• Written informed consent and any locally required authorization (e.g., HIPAA in the USA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 60 days after the final dose of KTN3379. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as 12 months with no menses without an alternative medical cause)
• Nonsterilized males who are sexually active with a female partner of child-bearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of KTN3379.
• Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
• Adequate bone and marrow function as defined below:
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count ≥ 1500/mm3
• Platelet count ≥ 100,000/mm3
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×ULN
• Bilirubin ≤ 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ≤ 5 × ULN
• Serum creatinine ≤ 1.5 g/dL
• Normal PT or INR and aPTT

You may not qualify if:

• Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
• Immunosuppressive or systemic steroids medication within 7 days before the first dose of KTN3379 (inhaled and topical corticosteroids are permitted).
• Another invasive malignancy within 2 years prior to enrollment except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has/have been surgically cured
• Major surgical procedure within 30 days prior to Day 1 or incomplete recovery from any prior surgery
• Pregnancy or lactation
• Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled or idiopathic hypotension, unstable angina pectoris, cardiac arrhythmia including atrial fibrillation, significant cardiac conduction abnormalities including prolongation of QTc interval or BBB, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
• Patients with a left ventricular cardiac ejection fraction \< 50% as assessed by an echocardiogram or MUGA scan
• Patients with prior primary treatment for head and neck cancer (e.g. chemoradiation or radiation alone).

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Duvvuri U, George J, Kim S, Alvarado D, Neumeister VM, Chenna A, Gedrich R, Hawthorne T, LaVallee T, Grandis JR, Bauman JE. Molecular and Clinical Activity of CDX-3379, an Anti-ErbB3 Monoclonal Antibody, in Head and Neck Squamous Cell Carcinoma Patients. Clin Cancer Res. 2019 Oct 1;25(19):5752-5758. doi: 10.1158/1078-0432.CCR-18-3453. Epub 2019 Jul 15.

  PMID: 31308059 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 17, 2015
• Study Start: October 1, 2015
• Primary Completion: September 22, 2016
• Study Completion: October 10, 2016
• Last Updated: August 1, 2019

Record last verified: 2017-05

Locations

US (2)